UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056141 |
|---|---|
| Receipt number | R000064143 |
| Scientific Title | Research of intracutaneous mechanism in the ochronosis |
| Date of disclosure of the study information | 2024/11/13 |
| Last modified on | 2024/11/13 13:52:25 |
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Basic information
Public title
Research of skin mechanism in the hyperpigmentation
Acronym
Research of skin mechanism in the hyperpigmentation
Scientific Title
Research of intracutaneous mechanism in the ochronosis
Scientific Title:Acronym
Research of intracutaneous mechanism in the ochronosis
Region
| Japan |
Condition
Condition
Ochronosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Collecting skin samples from the ochronosis site, and clarifying the pathological mechanism of by analyzing gene expression.
Basic objectives2
Others
Basic objectives -Others
Pathophysiological mechanism
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparative analysis of gene expression between ochronosis sites and normal skin sites.
Key secondary outcomes
Analysis of interaction between skin condition and gene expression in ochronosis sites and normal skin sites.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Persons who have received an explanation of this study, understand it, and agree to participate in the study of their own free will (persons who have given their informed consent).
(2) Persons who are recognized the symptom of ochronosis.
(3) Persons who are able to fill out the consent form and other documents.
Key exclusion criteria
(1) Persons with a history of severe hepatic disorder, renal disorder, or myocardial infarction.
(2) Persons with severe anemia.
(3) Persons with a keloid constitution (scars easily become red and swollen and are difficult to heal).
(4) Persons who have diabetes mellitus.
(5) Persons who are taking antithrombotic medicines.
(6) Pregnant, lactating mothers and those who plan to become pregnant during the study period.
(7) Persons with cold symptoms or fever of 37.5 degrees Celsius or higher (Exclusion criteria only on the day of the visit; temperature will be checked at the reception desk).
(8) Others whom the doctors involved in the research deem inappropriate.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Ishida |
| Middle name | |
| Last name | Waka |
Organization
Waka skin care clinic
Division name
Dermatology Aesthetic dermatology
Zip code
943-0146
Address
4 Toyoba, Joetsu, Nigata
TEL
025-525-4112
waka5868t@mac.com
Public contact
Name of contact person
| 1st name | Nakayama |
| Middle name | |
| Last name | Kazuki |
Organization
POLA Chemical Industries, Inc.
Division name
Frontier Research Center
Zip code
244-0812
Address
560 kashio-cho, Totsuka-ku, Yokohama
TEL
0458267232
Homepage URL
kazuki-nakayama@pola.co.jp
Sponsor or person
Institute
POLA Chemical Industries, Inc.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamauchi Clinic IRB
Address
1-15-19, Jiyugaoka, Meguro Ku, Tokyo To, Japan
Tel
03-5575-5862
c-irb_ug@neues.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-diseased sites will be used as background factors of participants for comparison, and gene expression information from skin tissues collected from diseased and non-diseased sites will be compared and analyzed to elucidate the relevance of changes in gene expression at diseased sites.
Management information
Registered date
| 2024 | Year | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064143
